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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520031-33-00 | Other Identifier | Clinical Trials Information System (CTIS) |
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This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A1 (Part A): BLU-808 | Experimental | BLU-808 will be administered orally. |
|
| Arm A3 (Part A): BLU-808 | Experimental | BLU-808 will be administered orally. |
|
| Arm B (Part B): BLU-808/Placebo | Experimental | BLU-808 or matching placebo will be administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-808 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Day 1 through Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12 | CTT is the temperature at which CIndU symptoms appear. | Baseline, Week 12 |
| Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blueprint Medicines | Contact | 1-888-258-7768 | medinfo@blueprintmedicines.com | |
| Blueprint Medicines, EU Contact | Contact | +31 85 064 4001 | medinfoeurope@blueprintmedicines.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allervie Clinical Research | Recruiting | Birmingham | Alabama | 35209 | United States | |
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Arms A1 and A3 are non-randomized and open label. Arm B is randomized and double blind.
| Placebo | Drug | Oral administration |
|
TFS is a measure of CIndU trigger thresholds and disease activity.
| Baseline, Week 12 |
| Part A and Part B: Complete Response Rate | Week 12 |
| Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12 | Baseline, Week 12 |
| Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12 | Baseline, Week 12 |
| Part A and Part B: Area Under the Curve (AUC) of BLU-808 | Day 1 to Day 57 |
| Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808 | Day 1 to Day 57 |
| Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808 | Day 1 to Day 57 |
| Part A and Part B: Apparent Clearance (CL/F) of BLU-808 | Day 1 to Day 57 |
| Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808 | Day 1 to Day 57 |
| Part A and Part B: Terminal Half-life (t½) of BLU-808 | Day 1 to Day 57 |
| Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12 | UAS7 is a patient-reported outcome used to assess symptoms in participants with CSU. | Baseline, Week 12 |
| Acuro Research, Inc. |
| Recruiting |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Modena Allergy & Asthma Clinical Research - La Jolla | Recruiting | La Jolla | California | 92037 | United States |
| Allergy & Asthma Associates of Southern California | Recruiting | Laguna Niguel | California | 92677 | United States |
| Allergy & Asthma Medical Group and Research Center | Recruiting | San Diego | California | 92123 | United States |
| Allergy Affiliates Inc. | Recruiting | Bradenton | Florida | 34208 | United States |
| University of South Florida | Recruiting | Tampa | Florida | 33613 | United States |
| Treasure Valley Medical Research | Recruiting | Boise | Idaho | 83706 | United States |
| Endeavor Health | Recruiting | Northbrook | Illinois | 60062 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Recruiting | Indianapolis | Indiana | 46250 | United States |
| Southern Indiana Clinical Trials | Recruiting | New Albany | Indiana | 47150 | United States |
| The Indiana Clinical Trials Center | Recruiting | Plainfield | Indiana | 46168 | United States |
| Equity Medical - Bowling Green | Recruiting | Bowling Green | Kentucky | 42104 | United States |
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21224 | United States |
| Institute For Asthma & Allergy | Recruiting | Wheaton | Maryland | 20902 | United States |
| Chesapeake Clinical Research | Recruiting | White Marsh | Maryland | 21236 | United States |
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| The Clinical Research Center LLC. | Recruiting | St Louis | Missouri | 63141 | United States |
| Montana Medical Research, Inc. | Recruiting | Missoula | Montana | 59808 | United States |
| Equity Medical (at Cameron Dermatology) - New York | Recruiting | New York | New York | 10023 | United States |
| Bernstein Clinical Research Center | Recruiting | Cincinnati | Ohio | 45236 | United States |
| Allergy & Clinical Immunology Associates | Recruiting | Pittsburgh | Pennsylvania | 15241 | United States |
| National Allergy, Asthma & Urticaria Centers of Charleston | Recruiting | Charleston | South Carolina | 29407 | United States |
| Medical University of South Carolina (MUSC) | Recruiting | Charleston | South Carolina | 29425 | United States |
| Reveal Research Institute | Recruiting | Dallas | Texas | 75235 | United States |
| Austin Institute for Clinical Research | Recruiting | Pflugerville | Texas | 78660 | United States |
| Odense University Hospital - Odense | Recruiting | Odense | 5000 | Denmark |
| Fraunhofer-Institut fuer Translationale Medizin und Pharmakologie ITMP - Standort Berlin | Recruiting | Berlin | 12203 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden | Recruiting | Dresden | 01307 | Germany |
| Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet | Recruiting | Frankfurt am Main | 60596 | Germany |
| Medizinische Hochschule Hannover (MHH) | Recruiting | Hanover | 30625 | Germany |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz | Recruiting | Mainz | 55131 | Germany |
| Universitaetsklinikum Tuebingen | Recruiting | Tübingen | 72016 | Germany |
| Azienda Ospedale - Università Padova | Recruiting | Padova | 35128 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Umberto | Recruiting | Rome | 00161 | Italy |
| Centro Ricerche Cliniche di Verona s.r.l. | Recruiting | Verona | 37134 | Italy |
| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitari de Bellvitge | Recruiting | Barcelona | 08907 | Spain |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | 29010 | Spain |
| National Taiwan University Hospital Hsin-Chu Branch | Recruiting | Hsinchu | 300 | Taiwan |
| Kaohsiung Veterans General Hospital (KSVGH) | Recruiting | Kaohsiung City | 813414 | Taiwan |
| Taipei Medical University - Shuang Ho Hospital | Recruiting | New Taipei City | 235 | Taiwan |
| China Medical University Hospital | Recruiting | Taichung | 40402 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 100225 | Taiwan |
| Linkou Chang Gung Memorial Hospital (CGMHLK) | Recruiting | Taoyuan City | 105406 | Taiwan |
| ID | Term |
|---|---|
| D000094482 | Chronic Inducible Urticaria |
| D000080223 | Chronic Urticaria |
| D000096703 | Cold Urticaria |
| C536612 | Familial dermographism |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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